Myocardial Perfusion Changes Following Optimal Medical Treatment in Symptomatic Hypertrophic Cardiomyopathy (oHCM)

August 24, 2025 updated by: Daniel Dalos, Medical University of Vienna

Background: Microvascular dysfunction is a hallmark of hypertrophic obstructive cardiomyopathy (HOCM) and can be visualized non-invasively using cardiac magnetic resonance (CMR) perfusion imaging. In parallel, the six-minute walk test (6MWT) is an established clinical tool to assess submaximal exercise capacity in patients with structural heart disease. Despite its widespread use, the relationship between objective changes in myocardial perfusion and functional improvements assessed by the 6MWT remains insufficiently explored in patients with HOCM on optimal medical therapy (OMT).

Aim:This study aims to evaluate whether changes in functional capacity, measured by the 6MWT, correlate with changes in myocardial perfusion reserve (MPR) in HOCM patients treated with OMT.

Methods: We will include patients diagnosed with obstructive HCM who previously underwent clinically indicated CMR perfusion scans for risk stratification. These patients are regularly followed in the HCM outpatient clinic of the Medical University of Vienna, where standardized 6MWTs are performed in routine care. Approximately one year after the baseline CMR, a follow-up CMR will be conducted to assess changes in perfusion parameters. This second CMR is clinically justified for improved individual risk stratification as recommended by the 2023 ESC Guidelines on Cardiomyopathies.

The primary objective is to assess the correlation between the change in the walking distance in the 6MWT and the change in MPR over a one-year interval. Secondary endpoints include changes in myocardial blood flow (MBF) at rest and during pharmacological stress. All assessments will be integrated with clinical, echocardiographic, and laboratory evaluations.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with oHCM on maximal tolerated background therapy which will receive mavacamten as add-on

Description

Inclusion Criteria:

  • Age > 18 years
  • Willingness to provide written informed consent
  • Diagnosis of obstructive HCM based on ESC 2023 criteria
  • Planned CMR with myccardial perfusion for clinical purposes
  • Receiving guideline-conform OMT
  • Ability and willingness to undergo follow-up imaging and testing
  • Written informed consent

Exclusion Criteria:

  • Claustrophobia or other contraindication for CMR imaging
  • Significant coronary artery disease and/or prior stent implantation or coronary artery bypass graft surgery
  • History of sudden cardiac arrest or sustained ventricular arrhythmia 12 months prior to screening
  • Glomerular filtration rate < 30ml/min/m2
  • Significant hepatic impairment defined as 3x upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase; hepatic cirrhosis
  • Known allergy to contrast agent
  • Alternative disease causing hypertrophic cardiomyopathy (e.g. cardiac amyloidosis, Morbus Fabry)
  • Pregnant women (and women with childbearing potential with desire for pregnancy)
  • Breastfeeding women
  • Unwillingness to comply with the study protocol and its procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between myocardial perfusion reserve changes and changes in the performed distance in 6MWT.
Time Frame: One year of maximal tolerated dose of mavacamten
Correlation between myocardial perfusion reserve changes and changes in the performed distance in 6MWT.
One year of maximal tolerated dose of mavacamten

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 5, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

August 24, 2025

First Submitted That Met QC Criteria

August 24, 2025

First Posted (Actual)

September 2, 2025

Study Record Updates

Last Update Posted (Actual)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 24, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV027-1201
  • 1492/2025 (Other Identifier: Medical University of Vienna)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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